Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00684281
First received: May 21, 2008
Last updated: January 29, 2010
Last verified: January 2010
  Purpose

The aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change


Condition Intervention
Alzheimer's Disease
Other: Neurological and neuropsychological consultation, MRI
Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Characterize the clinical evolution of these subjects: escalation with appearance of an insanity (of type Alzheimer's disease or of another type: degenerations fronto-temporal, insanity with body of Lewy), stabilization even improvement. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict a stabilization or an improvement. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Improve the state of the knowledge on the origin of the confusions mnésiques isolated at the persons of fifty and more years old. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Determine if the ultra-premature diagnosis of MY at a stage where the hurts are still confined in the structures under - hippocampiques is possible. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: July 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Subject control
Other: Neurological and neuropsychological consultation, MRI
Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36
Experimental: 2
40 patients before hand include in a program
Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36

Detailed Description:

The syndrome of "amnestic Mild Cognitive Impairment" (aMCI) has been introduced for patients with intact activities of daily living, with a memory complaint and objective memory decline on neuropathological assessment, without significative change in other domains of cognition. Follow-up in these patients shows that the memory impairment may remain stable or improve, while it worsens or extends to other cognitive domains in others, indicating prodromal AD.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients beforehand include in the PHRC 2001 study (These patients presented to the inclusion in the PHRC 2001 a qualified board of amnestic Mild Cognitive Impairment [aMCI] or light cognitive confusion of type amnestic)
  • The patient must be affiliated to an insurance scheme disease to participate in this study

Exclusion Criteria:

  • For the magnetic resonance imaging: usual contraindications for an examination by MRI: claustrophobia, metal foreign bodies, pacemakers, etc.
  • Incapacitated to realize the neuropsychological evaluation because of medical intercurrentes disorders
  • Appointment of a guardian
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684281

Contacts
Contact: Matthieu CECCALDI, MD 49-138-5928 mceccaldi@mail.ap-hm.fr
Contact: Mira DIDIC, MD 49-138-5928 mira.didic@medecine.univ-mrs.fr

Locations
France
Hopital de la Timone- Service de neurologie et de neuropsychologie Recruiting
Marseille, France, 13005
Contact: Matthieu CECCALDI, MD    49-138-5928    mceccaldi@mail.ap-hm.fr   
Contact: Mira DIDIC, MD    49-138-5928    mira.didic@medecine.univ-mrs.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Matthieu CECCALDI, MD Assistance Publique des Hopitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique des Hopitaux de Marseille
ClinicalTrials.gov Identifier: NCT00684281     History of Changes
Other Study ID Numbers: 2007-A00851-52, 2007-27
Study First Received: May 21, 2008
Last Updated: January 29, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014